The FDA's Dueling Priorities

Kirsch's idea is that if the efficacy question is set aside, American citizens' right to safety might be more easily guarded, even as the regulation process is streamlined. Efficacy then could be sorted out in the medical journals and the market. But on closer inspection, this doesn't hold up, because safety and efficacy are inextricably entwined. Not just a mitigating factor against safety fears, efficacy is in fact a component of safety, which is defined as “a judgment of the acceptability of risk in a specified situation.” In other words, a product is deemed safe if its risks are more than compensated by its effectiveness at combatting the health problem, especially if that health problem is severe. Still, there is a good argument to be made that safety is not sufficiently weighted against efficacy.